Contract research and manufacturing services

Global pharmaceutical companies face major challenges as new product approvals decrease, due to high drug development costs, and existing patents expire. Outsourcing of clinical trials can result in lower costs and more efficient timelines, and India offers significant advantages. Global pharmaceutical companies have either entered into or significantly expanded operations in India in the fields of drug discovery, contract manufacturing and clinical research. India, with a large patient population and genetic pool, can provide both cost savings and speedier trials. Its skilled manpower contributes to the R&D and manufacturing processes. India has emerged as a critical component for drug companies seeking efficiencies of cost and time.Following an overview of the contract research and manufacturing services (CRAMS) and their emergence in India, the authors discuss the legal and regulatory scenario and major concerns and issues. Other topics include service agreements, dispute resolution and contract negotiations, followed by a discussion of the outlook for CRAMS in India. The conclusion includes several appendices, which offer a list of major players in the field and various forms for use in license applications.